Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07832487

Strategy for Managing Urinary Incontinence With PRP

Urinary incontinence is a public health issue; in France, approximately 3 million women are affected.

Current treatment options-particularly surgical procedures involving the use of prosthetic materials-are being called into question. In 2019, the use of vaginal prostheses for prolapse was banned. The two sub-urethral sling (SUS) techniques are being challenged at medical conferences and within scientific committees, as they can lead to adverse effects and disastrous complications. Patient advocacy groups are emerging (such as "Balance ta Bandelette"), and media reports are proliferating to pressure authorities to withdraw all prosthetic materials from the market.

PRP (Platelet-Rich Plasma) is a technique widely used in cosmetology and rheumatology that could also be applied to the treatment of urinary incontinence. It is known to stimulate the body's natural repair mechanisms, thereby improving tissue nutrition. It is also believed to exert a mechanical effect similar to that of slings.

Consequently, an injection into the anterior vaginal wall-a relatively painless procedure performed adjacent to the mid-urethra-could initially act as a bulking agent and subsequently promote tissue regeneration, mimicking the effect of a sling in cases of urethral hypermobility, while also strengthening the sphincter in cases of sphincter deficiency.

This study therefore aims to evaluate this treatment approach for patients seeking alternatives to slings.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Platelet Rich Plasma Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital privé Dijon Bourgogne

Dijon, 21100, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patient aged 18 to under 80 years,
  • Diagnosis of pure or mixed stress urinary incontinence due to urethral hypermobility or sphincter insufficiency,
  • ICIQ score greater than or equal to 7,
  • USP score > 2 and < 7,
  • Failure of pelvic floor rehabilitation and desire for treatment,
  • Patient affiliated with or a beneficiary of a social security scheme, in accordance with Article L.1124-1 of the Public Health Code,
  • Free, informed, and signed consent.

Exclusion criteria

  • Patient with no prior pelvic floor rehabilitation,
  • Positive urine culture (ECBU) prior to the procedure,
  • Dysuria (assessed via the USP questionnaire and uroflowmetry: pre-intervention post-void residual volume measurement),
  • Use of anticoagulants within the 7 days preceding the scheduled procedure,
  • Patient suffering from cancer or a hematological disorder,
  • Adult under guardianship, curatorship, or other legal protection; deprived of liberty by judicial or administrative decision; or hospitalized without consent,
  • Pregnant, breastfeeding, or recently delivered woman,
  • Patient planning a pregnancy during the study period.

Treatment and study plan

Plasma rich platelet injection

Biological

PRP is derived from autologous blood collected in a tube containing an anticoagulant (sodium citrate) and subjected to a centrifugation protocol. Centrifugation separates the collected blood into distinct fractions: Platelet-Poor Plasma (PPP, representing 5% of the blood) at the top; Platelet- and Fibrinogen-Rich Plasma (PRP, representing 40% of the blood) in the middle; and granulocytes and leukocytes (representing 55% of the blood) at the bottom of the tube.

Once harvested from the red blood cell supernatant, the platelet concentrate is activated (using thrombin or calcium chloride) to trigger the release of a maximum amount of mediators-known as the secretome-which can contain up to 800 protein constituents.

Sub-urethral PRP injection (mid-urethra) is done by the gynecologist three times in a row at one-month intervals.

blood test

Biological

10 mL of blood is required to subsequently use the REGEN tube.

cytobacteriological examination of urine

Biological

Urine culture to be performed before each PRP injection.

Questionnaire and Physical Exam

Other
  • EVA pain score
  • 4-question neuropathic pain questionnaire
  • International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form
  • Urinary symptom profile questionnaire
  • Patient Global Impressions Improvement

Primary outcomes

  1. Achievement of the Clinically Important Difference (CID) in the ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) score

    Time frame: three months

    Achievement of the Clinically Important Difference (CID) in the ICIQ-UI-SF score 12 months after a protocol of three monthly vaginal injections.

    The questionnaire consists of 4 items :

    • Frequency or urinary incontinence
    • Amount of leakage
    • Overall impact of urinary incontinence
    • Self-diagnostic item The combined score ranges from 0 to 21, and a higher score means a greater reported symptom burden and a bigger impact on daily life. Score the self-diagnostic item separately, it doesn't get added to the total.

Interested in participating?

Not yet recruiting

Trial opening soon.

Get Notified

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

Study of the Strategy for Managing Urinary Incontinence With PRP

Acronym: PRPIU

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.